Each day, more and more vendors and manufacturers are selling hearing aid devices, personal sound amplification products, and applications in stores or online that are marketed to those with mild-to-moderate hearing loss to enhance and/or amplify sounds. ASHA has concerns regarding consumer safety in the use of these products-especially when an audiologist is not involved-and has been communicating with the U.S. Food and Drug Administration regarding oversight of these products.

Regulations

U.S. Food and Drug Administration (FDA) Oversight

Since enactment of the Federal Food, Drug, and Cosmetic Act of 1938 and as amended by the Medical Device Regulation Act of 1976, the FDA has provided oversight for the distribution and dispensing of hearing aids. However, a market has evolved that teeters on the edge of selling hearing aids as non-regulated PSAPs. ASHA has found that there are numerous distributors in the marketplace that are selling hearing aids but are marketing their devices to consumers as sound amplifying products, because the FDA is not involved in the oversight or distribution of these devices. However, ASHA is concerned for the population of individuals who may be purchasing these devices without seeking guidance from an audiologist.

Hearing Aids: FDA regulations require a medical examination by a licensed physician or a suitable waiver before any hearing aid device can be distributed or dispensed. Pursuant to C.F.R. §801.421, a prospective hearing aid user must provide to the hearing aid dispenser a written statement from a licensed physician that the prospective user has been medically evaluated and is a candidate for a hearing aid. This evaluation must occur within 6 months prior to the date of purchase of the hearing aid. The regulations further state that, following the medical evaluation, the physician will give the consumer a written statement indicating the fact that his or her hearing loss has been medically evaluated and that the consumer may be considered a candidate for hearing aid use. The physician will then refer the consumer to an audiologist or a hearing aid specialist, as appropriate, for a hearing aid evaluation. If 18 years of age or older, the prospective user may waive this requirement for medical evaluation, provided that the prospective user signs a waiver statement under the conditions outlined in this regulation. Children (age less than 18 years) are not eligible for a waiver.

Personal Sound Amplification Products (PSAPs):Personal sound amplification products (PSAPs) are not intended to improve hearing for individuals with hearing loss. They are intended to amplify environmental sound for consumers with normal hearing. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure, or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Federal Food, Drug, and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with the U.S. Food and Drug Administration. See FDA Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.

FDA Issues Draft Guidance Documents (November 7, 2013)The FDA issued a draft Guidance Document that is designed to further clarify the regulatory distinctions between hearing aids and personal sound amplification products. The FDA's guidance document takes a tougher stance on PSAP manufacturers that market their products to consumers with hearing impairment and use subtle references to their hearing loss. It offers examples of situations where PSAPs are used versus hearing aids. ASHA submitted comments [PDF] supporting the stronger guidance and welcomed the additional examples where the FDA sought to distinguish PSAPs from hearing aids. Additional comments encouraged the use of labelling on all PSAPs to advise consumers that such products do not address medical conditions and the need for them to see hearing health professionals be included in the guidelines.

State Legal Challenges to Online Sales of Hearing Aids and Devices

California, Florida, Missouri, Texas, and other states have all addressed whether they believe restrictions on the sales of online hearing aids in relation to FDA requirements are valid.

California

In 2013, California filed an exemption with the FDA that it wanted the consumer to visit face to face with a physician. The waiver request was published in the Federal Register, but there is no word from the FDA on a decision to exempt California from federal preemption of FDA disclosure and waiver requirements.

Florida

Florida had a ban on Internet sales, but vendors have continued to make sales despite it.

Missouri

In Missouri Board of Examiners for Hearing Instrument Specialists v. Hearing Help Express, Inc., 447 F.3d 1033 (2006), the Board of Examiners brought an action against Hearing Express, an Illinois corporation, to stop it from selling hearing aids online to residents of Missouri without the prior fitting or testing required by state law. Hearing Express argued that the Missouri statute was preempted by the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act. The 8th Circuit Court of Appeals concluded that the requirements of Missouri law were in addition to the federal requirements applicable to the sale of hearing aids and that they directly related to the safety of consumers and the effectiveness of the devices. The Missouri statute, therefore, "interfere[s] with the execution and accomplishment of the objectives of the FDA's hearing aid regulation," 45 Fed. Reg. at 67327, and must be deemed preempted by the MDA. Missouri's ban was overturned by the 8th Circuit (effectively invalidating any online bans in Arkansas, Iowa, Minnesota, Missouri, Nebraska, North Dakota, and South Dakota).

Texas

In 2007, a Texas Attorney General's (AG's) Opinion on mail order hearing aids was requested by the Texas Hearing Fitters Committee. The issue was the Texas AG's interpretation of the constitutionality of Texas requirements for an audiological examination and the prohibition against hearing aids ordered by mail. The AG considered whether federal law preempted the Texas requirements. The AG found that the federal regulation, 21 C.F.R. § 801.421(a)(2006), restricted the sale of a hearing aid to an individual who has undergone a medical evaluation in the past 6 months, but allows a fully informed adult to waive the evaluation. However, under Texas law, subsection 402.451(a)(6), an audiologic evaluation was mandatory, and the state provision imposed a requirement that was different from, or in addition to, a requirement in the federal law. Similarly, the federal hearing aid regulation did not contain a prohibition against the sale of hearing aids through the mail. See 21 C.F.R. § 801.421 (2006). On the other hand, subsection 402.451(a)(7) of the Texas law prohibited the sale of hearing aids by mail. Such a prohibition is a requirement that was different from, or in addition to, the requirements of the federal law, the AG noted. Thus, the Texas AG opined that both subsections of Texas law imposed requirements that were different from, or in addition to, the federal requirements and-because both related to the effectiveness and safety of a hearing aid device-the Texas requirements were expressly preempted by the FDA law.

The Texas AG interpreted the FDA guidelines on the medical waiver requirement to mean a consumer did not have to get an audiologic evaluation to purchase a hearing aid online in the state. The AG further noted that no federal law or regulation imposed a cut-off date on a state's ability to request an exemption or waiver from the federal preemption imposed by FDA law, although the extent to which such request received consideration was subject to the FDA's discretion. Thus, the AG concluded that a state would need to file a waiver from the guidelines with the FDA to require a consumer to have face-to-face visit with a hearing health professional.

Online Retailers

There are numerous vendors selling hearing aids at a low cost online or in retail stores, including big box retailers Costco (uses audiologists) and Wal-Mart (sells over-the-counter). Because of the rapid growth of online retailers and manufacturers, it is becoming an ever-increasing battle for hearing health organizations to keep track of all the players and to report those who may be marketing hearing aids as PSAPs or failing to comply with FDA disclosure and waiver requirements for the sale of hearing aids. We do not imply that the following vendors are not in compliance with FDA standards, but list them as examples of the diversity of players in the marketplace.

Health Insurance and Online Hearing Aid Sales

The collaboration between UnitedHealth Group and its subsidiary, hi HealthInnovations, is the first model to sell hearing aids off the Internet as an insurance benefit.

New to the Market

Phone Applications

Apple and Android devices have a number of apps marketed toward those who are deaf or hard of hearing. Some of them are even designed to test your hearing. Others offer amplification.

Health Care Services

There are multiple health care service companies sprouting up as well. Vision Hearing Alliance (VHA), a nationwide organization, has a business model to incorporate hearing into vision services. VHA describes a hearing health professional as either a licensed audiologist or hearing instrument specialist.

ASHA Corporate Partners

About Us

The American Speech-Language-Hearing Association (ASHA) is the national professional, scientific, and credentialing association for 198,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students.